The FDA has approved Novartis’ Rhapsido (remibrutinib) for adults with symptomatic dermographism whose symptoms are inadequately controlled with H1 antihistamines.
Rhapsido is the first treatment approved for symptomatic dermographism, according to an Oct. 7 news release. The oral selective BTK inhibitor is also the only prescription treatment approved for both chronic spontaneous urticaria and symptomatic dermographism when antihistamines fail.
The approval was supported by the phase 3 REMODEL-1 and REMODEL-2 studies. At week 12, 29.3% of patients receiving Rhapsido achieved the study’s measured response compared with 14% receiving placebo.
